e-Public Policy Update - February 2013

Contents:

  • ASM Comments on Proposed HHS Funding Framework for (HPAI) H5N1 Research
  • Research Budget Update
  • ASM Supports Agriculture Research
  • Public and Scientific Affairs Board Meeting
  • LRN Sentinel Protocol Revision
  • CDC Partner Call on Upcoming Vital Signs Report on CRE
  • ASM Attends FDA Public Workshop on Burkholderia
  • Centers for Disease Control and Prevention Director Testifies on Flu
  • Department of Health and Human Services Issues Request for Comment: Input on Recommendations from the Council of Councils Working Group on Use of Chimpanzees in NIH-Supported Research
  • Minority Microbiology Mentor Newsletter

ASM Comments on Proposed HHS Funding Framework for (HPAI)H5N1 Research
On January 3, the Public and Scientific Affairs Board sent a letter to the National Institutes of Health (NIH) which included concerns and recommendations related to the November 27 2012 Proposed Framework for Guiding Health and Human Services (HHS) Funding Decisions about Highly Pathogenic Avian Influenza (HPAI) Gain-of-Function Research (http://oba.od.nih.gov/oba/biosecurity/meetings/Dec2012/Proposed_Framework_for_Guiding_HHS_Funding_Decisions_about_HPAI_H5N1_GOF-12-11-12.pdf). The letter stated that there is value in conducting gain-of-function research with HPAI H5N1 as long as the benefits outweigh the risks of the research. Public health benefits from this research include the development and assessment of vaccines, therapeutics, diagnostics and surveillance methodologies that protect the public against pandemics. The ASM letter said that the Framework document is an important step that should provide a path forward to continue H5N1 research safely, but that careful crafting of the Framework is essential because it will likely be a prototype for future protocols regarding dual use research of concern. The letter described concerns related to the process for departmental review and how it will be operationalized; classification of research; and criteria for requiring higher level review of proposals. The ASM letter is available on the ASM web page by clicking: January 7, 2013 - ASM Comments on Proposed Framework for Guiding HHS Funding Decisions about Highly Pathogenic Avian Influenza H5N1 Gain-of-Function Research. Ronald Atlas, Cochair of the PSAB Committee on Biodefense attended the NIH international Consultative Workshop on Gain-of-Function Research on Highly Pathogenic Avian Influenza Viruses on December 17-18.

Research Budget Activities Update
HR 8, the American Taxpayer Relief Act of 2012 (http://www.gpo.gov/fdsys/pkg/BILLS-112hr8enr/pdf/BILLS-112hr8enr.pdf ), signed into law on January 2, delayed the automatic budget cuts known as sequestration, until March 1, 2013 with the implementation of cuts scheduled for March 27. The law reduced the total sequester amount over nine years, to $1.176 trillion, down $24 billion from the original $1.2 trillion, and reduced spending caps in FY 2013 and FY 2014. In FY 2013, HR 8 reduces the automatic budget cuts from $109 billion to $85 billion. The cuts for nondefense and defense discretionary funding are still more than 5 percent. The current FY 2013 Continuing Resolution (CR) which funds federal agencies including the Centers for Disease Control (CDC), Department of Agriculture (USDA), National Institutes of Health (NIH), National Science Foundation (NSF) and Department of Energy (DOE), among others, is set to expire on March 27. Congress may restructure the sequestration cuts when it considers the FY 2013 continuing resolution carrying federal funding through the rest of the fiscal year. Information on budget issues will be posted on the ASM public policy webpage at: http://www.asm.org/index.php/public-policy2/126-whats-new-in-public-policy/whats-new-in-policy/7470-radfy2013  

In February, ASM continued to inform policymakers about the damaging impact sequestration would have on research and public health programs. The ASM sent a Legislative Alert asking members to communicate with policymakers about the importance of federal investment in research and public health, and the devastating impacts that sequestration would bring.

On January 30, ASM staff attended a meeting at the White House with staff in the Offices of Science and Technology Policy and Public Engagement to discuss policy issues impacting the research community including sequestration and immigration reform.  

ASM, as a member of the Ad Hoc Group for Medical Research, joined more than 270 organizations and endorsed a letter sent to Congress on February 11 that urged policymakers to avoid devastating cuts to the National Institutes of Health (NIH) through sequestration and other potential funding shortfalls in Fiscal Years 2013 and 2014. The letter outlined impacts that continued cuts would have on both human health and the economy. A copy of the letter can be found on the ASM Public Policy webpage at: http://www.asm.org/images/CommunitySign-onFinal2-11-13.pdf

On February 6, Chuck Rice, chair of the PSAB Committee on Agricultural and Food Microbiology, met with congressional staff to discuss sequestration and its potentially devastating impacts as well as the importance of agricultural funding specifically, competitive grants funded by the USDA’s Agriculture and Food Research Initiative (AFRI.) Dr. Rice met with staff in the office of Majority Leader Eric Cantor, with senior staff of the Senate Committee on Appropriations, Agriculture Subcommittee and with staff in the offices of two new members of the House Agriculture Committee: Representatives Dan Benishek of Michigan and Ted Yoho of Florida.

ASM Supports Agriculture Research
ASM, a founding member of the Supporters of Agricultural Research (SOAR) coalition, attended the group’s third organizational meeting on January 10, in Washington, DC. Discussed were legislative updates relevant to agricultural research funding, future congressional strategies and the development of an aspirational budget document that outlines the importance of fully funding the Agriculture and Food research Initiative (AFRI) at $700 million. A non-partisan science based coalition; SOAR works with scientific organizations, consumer groups, major research institutions and private sector stakeholders to ensure that the Agriculture and Food research Initiative (AFRI) is adequately funded. For more information, please see the coalition website at: http://supportagresearch.org/

Public and Scientific Affairs Board Meeting
The ASM Public and Scientific Affairs Board (PSAB) held its annual meeting at ASM Headquarters on February 8. Members of the Board and ASM leadership attended the meeting. Policy makers from various federal agencies attended the meeting and presented and discussed information of interest to the microbiological community.

Anthony Fauci, M.D., Director, National Institute for Allergy and Infectious Diseases, NIH presented information about research and training policy issues of importance to the microbiological community, including the Proposed Framework for Guiding HHS Funding Decisions about Highly Pathogenic Avian Influenza H5N1 Gain-of-Function Research and Dual Use Research. He also discussed FY 2013 federal budget issues for NIH and NIAID, including sequestration.  

Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration, discussed issues of importance to microbiology and FDA, including antimicrobial resistance, food safety, global regulatory issues, drug discovery issues and the meningitis outbreak, as well as the impact of sequestration on FDA responsibilities.

Rima Khabbaz, M.D., Deputy Director for Infectious Disease, CDC discussed the importance of of enhancing bioinformatics capacity to enhance diagnostic and public health microbiology, CDC budget issues, influenza, antimicrobial resistance, outbreak investigations, including, West Nile Virus, the compounding pharmacy induced meningitis outbreak and Dengue, and emerging diseases.

Franca R. Jones, Ph.D., Assistant Director, Chemical and Biological Countermeasures, National Security & International Affairs Division, Office of Science and Technology Policy spoke about Dual Use Research of Concern (DURC) and the US Government policy of oversight of DURC. She outlined DURC activities including the moratorium on H5N1 research, upcoming Federal Register notices, the HHS Framework and the release of a Proposed Institutional Policy Release on DURC, which is anticipated in February 2013.

Catherine Woteki, Ph.D., Under Secretary for Research, Education, and Economics, Research, Education, and Economics, U.S. Department of Agriculture discussed research priorities at the USDA that impact microbiology, including food safety, food security, human nutrition, antimicrobial resistance and climate change. Dr. Woteki discussed the four agencies that deal primarily with these priority areas: ARS (agriculture research service), ERS(economic research service), NASS (national agricultural statistical service) and NIFA (National Institute of Food and Agriculture), which houses AFRI (Agriculture and Food Research Initiative), home to the USDA’s competitive grants program.

The PSAB reviewed policy issues of importance to microbiology and committee activities for the coming year.

LRN Sentinel Protocol Revision
On January 10, members of the Committees on Laboratory Practices and Professional Affairs met with APHL volunteers and staff to make final revisions to the Laboratory Response Network (LRN) Sentinel Level Clinical Laboratory Testing Protocols. These protocols have been developed for the purpose of promoting uniformity and standardization of testing among clinical laboratories. The tests and phenotypic characteristics described for each agent, i.e., suspected agent of bioterrorism or emerging infectious disease, are commonly performed conventional tests that allow the clinical laboratory to either rapidly rule out suspicious agents or refer them to the designated LRN Reference Laboratory. The American Society for Microbiology, in partnership with the Association of Public Health Laboratories (APHL) and the Centers for Disease Control and Prevention (CDC), serves as the lead in maintaining the protocols and making them available to the Sentinel Level Clinical Laboratory community. To see the revised protocols, please click on the link http://www.asm.org/index.php/guidelines/sentinel-guidelines.

CDC Partner Call on Upcoming Vital Signs Report on CRE

On January 17, CDC hosted a partner call for its upcoming Vital Signs on CRE. CRE, which stands for carbapenem-resistant Enterobacteriaceae, are a family of organisms that are difficult to treat because they have high levels of resistance to one of the broad spectrum Beta lactam antibiotics of last resort. Klebsiella species, Escherichia coli (E. coli) some species of Enterobacter are examples of CREs that have been associated with high mortality rates of 40-50%. The call was to inform partners of the publication and to answer any questions about CREs and how they are defined prior to the anticipated March publication. To see this and other issues of Vital Signs, go to http://www.cdc.gov/vitalsigns/ .

ASM Attends FDA Public Workshop on Burkholderia
In November 2012, the U.S. Food and Drug Administration’s Medical Countermeasures initiative (MCMi) brought together over 30 national and international speakers to discuss current data on the organism that causes glanders. Entitled “Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps”, the two day conference consisted of presentations on the following broad topics:

  • Public Health Emergencies: Preparedness for Melioidosis and Glanders
  • Current Knowledge of Clinical Disease in Humans
  • Diagnostics
  • Genomics and Strain Characterization
  • Animal Models
  • Candidate Medical Countermeasures
  • Scientific and Regulatory Challenges to Countermeasure Development

Most members of the genus Burkholderia have high intrinsic antibiotic resistance and the high mortality rates seen when infections with B. mallei and B. pseudomallei are present makes them potential biological warfare agents, as they target both humans and livestock. This meeting was co-sponsored by the Defense Threat Reduction Agency, the National Institutes of Health, the Centers for Disease Control and Prevention, the U.S. Army Medical Research Institute of Infectious Diseases, the Biomedical Advanced Research and Development Authority, the Chemical Biological Medical Systems Joint Project Management Office, the U.S. Strategic Command Center for Combating Weapons of Mass Destruction, and the Joint Science and Technology Office for Chemical and Biological Defense. For more information on the workshop, see http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/ucm323090.htm.

Centers for Disease Control and Prevention Director Testifies on Flu
CDC Director, Dr. Thomas Frieden, testified before the Committee on Energy and Commerce, Subcommittee on Oversight and Investigations.  The hearing, entitled “Influenza: Perspective on Current Season and Update on Preparedness,” will provide perspective on this year’s flu season and address ongoing efforts at the Federal level to prepare for and respond to future influenza outbreaks.  To read Dr. Frieden’s testimony, please see the CDC/W website: http://www.cdc.gov/washington/testimony/2013/t20130213.htm

Marcia Crosse: Director, Health Care of the Government Accountability Office also testified at the same hearing. Her testimony, “Influenza: Progress Made in Responding to Seasonal and Pandemic Outbreaks” is available on-line at: http://www.gao.gov/products/GAO-13-374T

Department of Health and Human Services Issues Request for Comment: Input on Recommendations from the Council of Councils Working Group on Use of Chimpanzees in NIH-Supported Research
The National Institutes of Health (NIH) Council of Councils received and adopted the recommendations and Report of the NIH Council of Councils Working Group on the Use of Chimpanzees in NIH Supported Research on January 22, 2013. The report is posted on the NIH Web site at http://dpcpsi.nih.gov/council/working_group_message.aspx. The agency will consider the recommendations contained in the report as the agency formulates policy. On February 5, the NIH announced the opening of a Request for Comment (RFC) period to collect input on the recommendations from interested parties. Comments will be accepted until Saturday, March 23, 2013. To read the complete Federal Register notice go to: http://www.gpo.gov/fdsys/pkg/FR-2013-02-05/pdf/2013-02507.pdf.

Minority Microbiology Mentor Newsletter
The February issue of the Minority Microbiology Mentor Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities. To read the issue click: Minority Microbiology Mentor Newsletter - February 2013.

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